Randomized Controlled Trial of Fluobeam® LX Compared With Clinical Assessment of Parathyroid Glands to Counteract Postoperatively Failing Parathyroid Function With Low Blood Calcium After Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 516
- 试验地点
- 5
- 主要终点
- Postoperative level of Parathyroid hormone (PTH)
研究概览
简要总结
The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy
详细描述
Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery.
Patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active Vitamin D analogue therapy for more than 6 months, are at increased risk of renal insufficiency. They also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. Patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. Finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication.
If, by using a technique for autofluorescence (Fluobeam® -LX), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease.
Patients undergoing total thyroidectomy are randomized to the use of Fluobeam® -LX to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). Outcome is evaluated by parathyroid hormon (PTH) levels the first postoperative day and the need for medication with calcium and Vitamin D up to 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participant is not informed of the assigned group, whereas the the care giver (surgeon) is informed due to the use (or not) of the Fluobeam®-LX.
Randomization is performed 1: 1 in blocks of 10 via the Eurocrine quality register platform.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
排除标准
- •Previous thyroid surgery
- •Previous parathyroid surgery
- •Concurrent parathyroid surgery
- •Renal insufficiency
- •Pregnancy
- •Breast feeding
- •Allergy (contrast agent, iodine)
- •Inability to understand study information
- •Patient unable to participate in planned follow-up program
研究组 & 干预措施
Fluobeam® LX
Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands
干预措施: Fluobeam® LX (Device)
Control
In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination).
结局指标
主要结局
Postoperative level of Parathyroid hormone (PTH)
时间窗: First postoperative day
Low plasma parathyroid hormone (PTH) (below the normal reference range)
次要结局
- Re-hospitalization due to hypocalcaemia(One month)
- Excised parathyroid glands(One week)
- Time for operation(Intraoperatively)
- Hospital stay(One week)
- Identification of parathyroid glands(Intraoperatively)
- Postoperative medication with oral calcium(At discharge (up to 7 days), at 1 month and at 6 months)
- Postoperative medication with Active vitamin D(At discharge (up to 7 days), at 1 month and at 6 months)
- Autotransplantation of parathyroid tissue(Intraoperatively)